Expiratory Muscle Training for Persons With Neurodegenerative Disease
Expiratory Muscle Training for Persons With Neurodegenerative Disease
What it found
The main measure showed a statistically significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Maximum Expiratory Pressure (MEP) | 0.00042 | ||
| Maximum Expiratory Pressure (MEP) | 0.0019 | ||
| Swallow-related Quality of Life (SWAL-QOL) | 0.004 | ||
| Swallow-related Quality of Life (SWAL-QOL) | 0.007 | ||
| Swallow-related Quality of Life (SWAL-QOL) | 0.014 | ||
| Swallow-related Quality of Life (SWAL-QOL) | 0.016 | ||
| Swallow-related Quality of Life (SWAL-QOL) | 0.016 | ||
| Swallow-related Quality of Life (SWAL-QOL) | 0.022 | ||
| Swallow-related Quality of Life (SWAL-QOL) | 0.027 | ||
| Swallow-related Quality of Life (SWAL-QOL) | 0.031 | ||
| Swallow-related Quality of Life (SWAL-QOL) | 0.036 | ||
| Swallow-related Quality of Life (SWAL-QOL) | 0.038 | ||
| Swallow-related Quality of Life (SWAL-QOL) | >0.05 | ||
| Swallow-related Quality of Life (SWAL-QOL) | > 0.05 | ||
| Swallow-related Quality of Life (SWAL-QOL) | > 0.05 | ||
| Maximum Expiratory Pressure (MEP) | 0.899 | ||
| Maximum Expiratory Pressure (MEP) | 0.946 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- EMST
Placebo
- Sham
Results by group
Maximum Expiratory Pressure (MEP)
at baseline and again after 5-week EMST exercise
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Arm 1: EMST | 78.6 cm H2O | 30.72 (Standard Deviation) | 20 |
| Arm 2: Sham | 75.56 cm H2O | 27.68 (Standard Deviation) | 16 |
| Arm 1: EMST | 99.00 cm H2O | 32.97 (Standard Deviation) | 20 |
| Arm 2: Sham | 99.38 cm H2O | 37.59 (Standard Deviation) | 16 |
Arm 1: EMST
Arm 2: Sham
Arm 1: EMST
Arm 2: Sham
p = 0.899
Penetration-Aspiration Scale Score
at baseline and again after 5-week EMST exercise
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Arm 1: EMST | 40.0 percentage of group participants | 20 | |
| Arm 2: Sham | 14.3 percentage of group participants | 14 | |
| Arm 1: EMST | 45.0 percentage of group participants | 20 | |
| Arm 2: Sham | 64.3 percentage of group participants | 14 | |
| Arm 1: EMST | 15.0 percentage of group participants | 20 | |
| Arm 2: Sham | 21.4 percentage of group participants | 14 |
Swallow-related Quality of Life (SWAL-QOL)
at baseline and after 5-week of EMST exercise
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Arm 1: EMST | 83.3 percentage of possible perfect score | 11.5 (Standard Deviation) | 19 |
| Arm 2: Sham Group | 81.4 percentage of possible perfect score | 10.9 (Standard Deviation) | 13 |
| Arm 1: EMST | 88.1 percentage of possible perfect score | 10.8 (Standard Deviation) | 19 |
| Arm 2: Sham Group | 84.4 percentage of possible perfect score | 8.5 (Standard Deviation) | 13 |
| Arm 1: EMST | 90.0 percentage of possible perfect score | 20 (Standard Deviation) | 19 |
| Arm 2: Sham Group | 80.8 percentage of possible perfect score | 25 (Standard Deviation) | 13 |
| Arm 1: EMST | 97.4 percentage of possible perfect score | 7.3 (Standard Deviation) | 19 |
| Arm 2: Sham Group | 86.2 percentage of possible perfect score | 18.9 (Standard Deviation) | 13 |
| Arm 1: EMST | 73.5 percentage of possible perfect score | 16.9 (Standard Deviation) | 19 |
| Arm 2: Sham Group | 75.4 percentage of possible perfect score | 13 (Standard Deviation) | 13 |
| Arm 1: EMST | 82.4 percentage of possible perfect score | 16.6 (Standard Deviation) | 19 |
| Arm 2: Sham Group | 77.6 percentage of possible perfect score | 11.6 (Standard Deviation) | 13 |
| Arm 1: EMST | 84.2 percentage of possible perfect score | 16.2 (Standard Deviation) | 19 |
| Arm 2: Sham Group | 83.1 percentage of possible perfect score | 13.5 (Standard Deviation) | 13 |
| Arm 1: EMST | 92.3 percentage of possible perfect score | 9.5 (Standard Deviation) | 19 |
| Arm 2: Sham Group | 83.6 percentage of possible perfect score | 15.8 (Standard Deviation) | 13 |
| Arm 1: EMST | 95.3 percentage of possible perfect score | 7 (Standard Deviation) | 19 |
| Arm 2: Sham Group | 91.2 percentage of possible perfect score | 13.1 (Standard Deviation) | 13 |
| Arm 1: EMST | 96.9 percentage of possible perfect score | 4.5 (Standard Deviation) | 19 |
| Arm 2: Sham Group | 91.2 percentage of possible perfect score | 9.8 (Standard Deviation) | 13 |
| Arm 1: EMST | 80.5 percentage of possible perfect score | 22.2 (Standard Deviation) | 19 |
| Arm 2: Sham Group | 79.2 percentage of possible perfect score | 14.8 (Standard Deviation) | 13 |
| Arm 1: EMST | 89.2 percentage of possible perfect score | 20.4 (Standard Deviation) | 19 |
| Arm 2: Sham Group | 84.6 percentage of possible perfect score | 11.3 (Standard Deviation) | 13 |
| Arm 1: EMST | 87.2 percentage of possible perfect score | 21.5 (Standard Deviation) | 19 |
| Arm 2: Sham Group | 83.4 percentage of possible perfect score | 16.5 (Standard Deviation) | 13 |
| Arm 1: EMST | 94.1 percentage of possible perfect score | 18.2 (Standard Deviation) | 19 |
| Arm 2: Sham Group | 90.2 percentage of possible perfect score | 13 (Standard Deviation) | 13 |
p = > 0.05
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Arm 1: EMST | 24 | 0 (0.0%) | |
| Arm 2: Sham Group | 18 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Maximum Expiratory Pressure (MEP)
at baseline and again after 5-week EMST exercise
Nerve conduction testsPenetration-Aspiration Scale Score
at baseline and again after 5-week EMST exercise
SafetySwallow-related Quality of Life (SWAL-QOL)
at baseline and after 5-week of EMST exercise
Quality of life (reported by participants)
Who could take part
Relapsing MS · 35 to 80
Show the full criteria
Inclusion criteria
* Multiple Sclerosis Participants * Diagnosis of primary, secondary, or relapsing-remitting MS by a neurologist * Over 85% of the patient populations that come from the study sites demonstrate relapsing-remitting MS with an average relapse frequency of once every 3 years Parkinson's Disease Participants * Hoehn \& Yahr, stage II and III as indicated by certified movement disorders neurologist All Participants * Between 35 and 80 years of age * Non-smoking or no smoking within the previous five years * No history of head and neck cancer, asthma or COPD, untreated hypertension * Sufficient facial muscle strength so as to achieve and maintain adequate lip closure around a circular mouthpiece * Cognition within normal limits as determined by the: Mini Mental Status Exam (MMSE; 1975No neurological (other than MS or PD) condition which adversely affects respiratory muscle or gas exchange system * Reduced MEP's compared to published normative data for age and sex * Reduced expiratory peak flow rates (6-8 L/s for young to middle age adults and 3.6 L/s for 65 and older) during voluntary cough production for age and sex (Bolser, personal communication; Smith-Hammond \& Goldstein, 2006) * Participant report of symptoms related to swallow impairment
Exclusion criteria
* DBS * COPD * Asthma * Smoking or smoking within preceding 5 years
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Respiratory difficulty is one of the primary factors leading to death in patients with Parkinson's Disease (PD) and Multiple Sclerosis. Both diseases are progressive degenerating diseases that cause difficulties in breathing, airway protection and swallowing. Patients with PD and MS typically become sedentary and lose endurance, maximal fitness levels and overall pulmonary function. Much of the research focus has been on the motor symptoms of PD and MS yet the pulmonary and swallowing complications are perhaps ultimately the most important disability as the diseases progress. The inability to generate adequate respiratory pressure is responsible for reduced cough magnitudes and cough response times. Cough is critical for the clearance of foreign materials in the airway helping to reduce infiltration of bacteria and subsequent respiratory infection. With reduced cough function an increased risk for pulmonary disease occurs due to a reduced ability to protect the airways. There are a number of promising outcomes from an expiratory strength-training program. By increasing expiratory muscle strength and expiratory pressure generation, effective breathing, clearance of the airway, and improved swallowing can occur. These explicit outcomes are predicted based on our experience with the use of an innovative device-driven, home-based expiratory strength training program focused on the expiratory muscles of respiration. This project focuses on following patients with PD and MS for an initial 5 weeks of strength training and them testing the outcome of a caregiver program for maintaining treatment effects.
Papers
Loading reviews and guidelines…
History
Started
Mar 2009
Main results due
Aug 2014
Finished
Aug 2014
Results posted
Nov 2016